Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair

Ghent University Hospital (UZ)

Status: Completed

Conditions: Ventral Hernia

Treatments: Procedure: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00572962

2007/268

Details and patient eligibility

About

1. General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery

2. Laparoscopic surgery

   • at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
   • with or without anchoring transparietal sutures or double crown technique

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written informed consent from the patient or his/her legal representative
• ventral hernia requiring elective surgical repair

Exclusion criteria

• no written informed consent
• 'hostile' abdomen; open abdomen treatment
• contraindication to pneumoperitoneum
• emergency surgery (incarcerated hernia)
• parastomal hernia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

1

Experimental group

Description:

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Treatment:

Procedure: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair